Novartis China's First Radiopharmaceutical Production Project in China Completes Main Construction on Schedule; Key Buildings Including Production Plant and Supporting Facilities Successfully Topped Out, Entering Interior Decoration Phase. The Novartis China radiopharmaceutical production project is located in the Haining County Nuclear Technology Application (Isotope) Industrial Park, Zhejiang Province, with an estimated total investment of 600 million RMB. According to the current progress, equipment installation and debugging are expected to begin in June 2025, with production capability anticipated by the end of 2026. After obtaining necessary regulatory approvals and permits, the project will have the capacity to supply innovative radioligand therapy drugs for precision oncology treatment to Chinese patients on a large scale.
Main Building of Novartis China's Radiopharmaceutical Production Project Successfully Topped Off
Novartis China's Radiopharmaceutical Production Project is the company's second innovative drug production base in China, intended for manufacturing internationally advanced radioligand therapy drugs. By introducing industry-leading automated production lines, the project will fully leverage Novartis' platform-level advantages in radioligand therapy research and development, production, supply, logistics support, and service assistance, achieving comprehensive digitalization of radioligand drug manufacturing, supply chain, and distribution processes in the Chinese market. This will more efficiently and accurately meet the needs of Chinese patients. In recent years, Novartis has actively collaborated with all parties in China’s healthcare system and radiopharmaceuticals-related industries, fully committing to advancing the improvement and development of China’s radiopharmaceutical healthcare system and industry. The successful topping-out of the Haining plant provides a strong boost for the timely completion and smooth operation of the entire project. Once operational, the project will help more Chinese patients access the innovative drugs they need in a timely and reliable manner.
The construction of this project broke ground in July 2024. From design to construction, it adopts advanced technologies and techniques in the industry, adhering to strict safety requirements and leading quality standards.Guided by Novartis' Life Safety Code, the project construction fully implements safety training, enforces strict management standards, and adopts preventive safeguard measures. Key risks of the project are controlled primarily through risk assessment, review of safety construction plans, and safety briefings. Effective safety communication is established to enhance personnel safety awareness. A safety experience area for working at heights and warning signs are set up, and workers are trained, communicated with, and undergo health and safety indicator checks to control the risks associated with working at heights. At the same time, on-site safety conditions are improved through safety inspections at different levels.As of the end of April 2025, the project construction has achieved a safety record of 200,000 consecutive man-hours without injury.
As of the end of April 2025, a safety record of 200,000 consecutive man-hours without injury has been achieved.
Radioligand therapy is an innovative conjugate drug that combines radionuclides with specific ligands targeting tumors.Novartis has been deeply engaged in radioligand therapy since 2017, which, together with chemotherapy, biologic therapy, gene and cell therapy, and xRNA therapy, forms the five major technology platforms that Novartis focuses on.
Currently, the biggest challenge encountered in the application of radioligand therapy lies in the unique "half-life" of radionuclides.An innovative drug of Novartis' targeted radioligand therapy has a shelf life of only 120 hours from the time of manufacture —To ensure the efficacy of the drug, the entire process from factory production, transportation and distribution, to patient medication must be completed within the 120-hour "golden rescue time.", which not only requires ensuring rapid production, high standards, and consistency during the manufacturing process but also places extremely high demands on the speed, resilience, and precise control of the entire transportation and distribution process.
To efficiently and accurately provide medications for patients around the world, Novartis has established radioligand therapy production bases globally and is committed to building a comprehensive logistics and service system. The Novartis China radiopharmaceuticals production project currently under rapid construction in Haiyan, Zhejiang, represents a key step in fulfilling Novartis’ commitment to the Chinese market.On the premise that radioligand therapy gains approval in China, the Novartis China radiopharmaceutical production project will join the radioligand therapy production bases established in the United States, Spain, Italy, and Japan to further enhance Novartis' global layout of radioligand therapy, better meeting the growing demands of patients in China and worldwide.
In China, the radiopharmaceuticals industry has become a strategically emerging industry that is prioritized and supported by the state, with numerous favorable policies introduced successively. Novartis has accumulated highly specialized expertise in the research and development, production, clinical application, as well as interdisciplinary and cross-industry collaboration in the field of radioligand therapy. It has submitted a policy recommendation report proposing to optimize and improve the clinical application system for nuclear medicine, scientifically differentiate radiopharmaceuticals from radioactive materials, refine relevant standards for the clinical use of radiopharmaceuticals, and update regulatory guidelines for radiopharmaceutical registration. The report also suggests further encouraging the research and development of radiopharmaceuticals, fostering collaboration among multiple stakeholders to jointly promote the upgrading of nuclear medicine diagnosis and treatment, and accelerating the establishment and development of the radioligand therapy ecosystem.
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